Protocol Number: 03-N-0049

Title:

Repetitive Transcranial Magnetic Stimulation in Chronic Stroke Patients. Dose Effect on Motor Cortex Excitability, Motor Performance, and Safety Using Different Stimulation Parameters.

Number:

03-N-0049

Summary:

This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabilitation study and confirm the safety of the procedure at these settings. Some previous studies using TMS to treat movement disorders such as Parkinson's disease have shown improvement in motor function; others have not. The results of this study may provide information to help researchers design better rehabilitation treatments after stroke.

Stroke patients with residual arm function and no history of seizures may be eligible for this study. The stroke must have occurred at least 6 months before entry into the study and must have affected only one side of the brain.

For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the outer part of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may affect movements or reflexes. Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Fifteen adult and impaired patients (right or left) with residual arm function who have had a single monohemispheric stroke (documented by CT or MRI) at least 6 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.

They should be able to perform the pinch task.

Their gender or ethnic origin will not provide bias for inclusion to the study.

All subjects will sign an informed consent prior to participation in the trial.

EXCLUSION CRITERIA:

Exclusion criteria for the trial will include any current medical or surgical condition or neurological or psychiatric illness.

Any individual who is on medication with potential influence on nervous system function such as stimulants, anxiolytics, hypnotics, antipsychotics, antiparkinsonians, antidepressants, and anticonvulsants, who has a pacemaker, an implanted medical pump, a metal plate, a metal plate or metal object in the skull or eye (for example after brain surgery) will be excluded.

Also excluded from the study will be: patients with more than one stroke, patients with large cortical, cerebellar, or brainstem lesions, patients unable to extend metacarpophalangeal (MP) joints at least 10-20 degrees, patients unable to extend the wrist at least 20 degrees, patients with substantially recovered motor function, patients with severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature, patients with severe spasticity/pain, patients with bilateral motor problems, patients with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less), patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, or others).

Patients with any history of seizure will be excluded.

Patients without any history of seizures, but with any sign of increased cerebral activity in the EEG will be excluded.

Special Instructions: Currently Not Provided

Keywords:

Rehabilitation

Plasticity

Frequency

Inhibition

Pinch

Recruitment Keywords:

Stroke

Conditions:

Cerebrovascular Accident

Investigational Drug(s):

None

Investigational Device(s):

rTMS, Magstim

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

[No authors listed] Stroke--1989. Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and other Cerebrovascular Disorders. Stroke. 1989 Oct;20(10):1407-31.

Matchar DB, McCrory DC, Barnett HJ, Feussner JR. Medical treatment for stroke prevention. Ann Intern Med. 1994 Jul 1;121(1):41-53.

[No authors listed] The uses of epidemiology in the study of the elderly. Report of a WHO Scientific Group on the Epidemiology of Aging. World Health Organ Tech Rep Ser. 1984;706:1-84. Review. No abstract available.

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